Medical device recalls Moderate risk

Beckman Coulter, Inc. recalls Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

Recall date
October 1, 2025
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0428-2026
FDA classification
Class II
Brand / firm
Beckman Coulter, Inc.
Sold / distributed
Worldwide

Why it was recalled

An internal investigation has determined that due to defective sub-components within the gantry assembly, a z-axis CAD movement motion error may occur and cause an analyzer to enter a Not Ready or Paused state, leading to a delay in obtaining results.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

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